Quality System Specialist

Job Title : Quality System Specialist

Length of Assignment : 12 months

Shift / Schedule Details : M-F 8am-5pm

Location : 100% Onsite in Holly Springs, NC 27540

Description :

This position has responsibilities that include providing technical expertise related to the process, equipment, and business systems that drive strategic improvements in the services provided to our customers. This role requires having a technical understanding of the QC function. Understanding of the technical scope of the QC function, how the function impacts QC customers, and ensuring compliance with Quality objectives is critical for this role. This role involves interaction within cross-functional teams between multiple departments, including other sites, and involves a high level of attention to detail to solve a range of routine and non-routine problems. The individual must be self-motivated and have good organization, and time management skills.

Major Accountabilities :

• Leads deviation (DR) investigations to adequately identify root cause and implement appropriate corrective and preventative actions (CAPAs) to prevent recurrence
• Initiates and performs EDMS workflows. Completes change control, self-inspection, and CAPA Actions
• Provides support with assigned business process systems to support QC - these systems include SAP, LIMS, EDMS, LMS, etc.
• Responsible for the Work Order Tracking system for tracking and coordinating the initiation, execution and completion of work orders
• Track metrics (KPIs) and project statuses. Well-developed presentation skills to deliver presentations to the team / dept and cross-functional groups
• Able to perform GMP documentation activities and follow specific schedules, with excellent communication skills
• Works within clearly defined standard operating procedures and / or scientific methods and adheres to quality guidelines
• Must demonstrate exceptional teamwork behaviors with going above and beyond to help others

Minimum Required Qualifications :

2+ years of experience in the vaccine manufacturing industry required

Bachelor's degree or associate degree in a scientific discipline required

Must be able to interpret & follow detailed instructions

Must be detail-oriented

Must possess excellent communication skills, both written and verbal

Must have some experience with technical writing (specific experience writing investigations is highly preferred)

Preferred / Nice to Have Qualifications :

Knowledge of GMPs

Knowledge of safety regulations

Knowledge of data integrity